Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)

Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study

This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis or rescue of single or multiple fraction radiation induced nausea and vomiting. This prospective study employs a parallel arm design, allowing for inclusion of patients with pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients receiving radiotherapy known to have a low or moderate emetogenic risk will receive every other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of rescue medication, and impact on quality of life will be monitored during and after radiation treatment completion.

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting
• Intervention / Treatment: Drug: Palonosetron; Radiation: Low or moderate risk radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Odette Cancer Centre, Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed consent
• Patient will receive radiation therapy to considered moderate risk (upper abdomen, upper and half body irradiation) or low risk (lower thorax and pelvis) emetogenic palliative radiotherapy.

• Patients will be grouped according to nausea and vomiting status at baseline as follows:

  • Group 1: Patient is experiencing no nausea and vomiting at baseline
  • Group 2: Patient is experiencing at least mild nausea and/or at least mild vomiting at baseline

Exclusion Criteria:

• Patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol RT.
• Patient received cranial RT within 7 days prior to commencement of protocol RT.
• Patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol RT.
• Patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol RT.
• Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties within 48 hours prior to protocol RT.
• Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties during or within 10 days following completion of protocol RT.
• Concurrent use of corticosteroids during protocol RT is not permitted, unless low dose corticosteroids (hydrocortisone) are used for cancer treatment
• Patient is allergic to protocol medication.
• Patient has a Karnofsky Performance Status score <40.
• Patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: No previous nausea and vomiting; Palonosetron 0.5 mg oral capsule given for the length of radiation treatment No previous nausea and vomiting 24 hours prior to radiotherapy	Drug: Palonosetron; Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT; Radiation: Low or moderate risk radiotherapy; Low or moderately emetogenic radiotherapy will be given to all patients on study.
Other: Previous nausea and/or vomiting; Palonosetron 0.5 mg oral capsule given for the length of radiation treatment Previous nausea and/or vomiting 24 hours prior to radiotherapy	Drug: Palonosetron; Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT; Radiation: Low or moderate risk radiotherapy; Low or moderately emetogenic radiotherapy will be given to all patients on study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy for prevention of nausea and vomiting events as measured by a daily diary	Primary outcome is to determine the efficacy of palonosetron for the prevention of radiation-induced vomiting in patients undergoing low or moderate emetogenic radiation therapy. Daily diary collects events of nausea and/or vomiting, and corresponding severity.	Day 0 to Day 10 post-radiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete prophylaxis of nausea	Proportion of patients achieving complete prophylaxis of nausea and not requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy	Day 0 to Day 10 post-radiation
Complete prophylaxis of vomiting	Proportion of patients achieving complete prophylaxis of vomiting without requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy	Day 0 to Day 10 post-radiation
Partial control of nausea	Proportion of patients achieving partial control of nausea during and in the 10 days following radiation therapy	Day 0 to Day 10 post-radiation
Partial control of vomiting	Proportion of patients achieving partial control of vomiting during and in the 10 days following radiation therapy	Day 0 to Day 10 post-radiation
Time to use of rescue medication	Median time from first fraction of radiation therapy to first use or increase in use of rescue medication	Day 0 to Day 10 post-radiation
Time to nausea	Median time from first fraction of radiation therapy to first episode or increase in episodes of nausea	Day 0 to Day 10 post-radiation
Time to vomiting	Median time from first fraction of radiation therapy to first episode or increase in episodes of vomiting	Day 0 to Day 10 post-radiation
Quality of life	Quality of life as measured by the EORTC QLQ-C15-PAL and the FLIE.	Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation.
Adverse effects	The side effects of constipation and headache will be monitored throughout the study period graded according to the CTCAE criteria.	Day 0 to Day 10 post-radiation

Collaborators and Investigators

• Sponsor: Dr. Edward Chow
• Investigators: Principal Investigator: Chow Edward, MBBS PhD, Odette Cancer Centre, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 7, 2017
• Study Completion (Actual): August 7, 2017

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: nausea; radiation; vomiting; anti-emetic drug
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: Palonosetron